Accuracy of Pulse Oximeters in Profound Hypoxia

Movano Health

Status: Completed

Conditions: Hypoxia

Treatments: Device: Pulse oximeter

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05920278

153-00381

Details and patient eligibility

About

The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. Two devices were placed on each subject with one on the finger and the other on the fingertip. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.

Enrollment: 11 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is in good general health with no evidence of any medical problems.
• Subject is fluent in both written and spoken English.
• Subject provided written informed consent and is willing to comply with the study procedures.
• Subject is willing to have their skin color assessed.

Exclusion criteria

• Subject is obese with a BMI over 30.
• Subject has a known history of heart disease, lung disease, kidney or liver disease.
• Subject has asthma, sleep apnea, or uses a CPAP.
• Subject has diabetes.
• Subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation.
• Subject has any other serious system illness.
• Subject is a current smoker.
• Subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly.
• Subject has a history of fainting or vasovagal response.
• Subject has a sensitivity to local anesthesia.
• Subject has Raynaud's disease.
• Subject has unacceptable collateral circulation based on an exam by the investigator.
• Subject is pregnant, lactating, or trying to get pregnant.
• Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures.
• Subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.

Trial design

11 participants in 1 patient group

Healthy Adult Volunteers

Description:

Minimum of ten (10) subjects meeting the eligibility criteria.

Treatment:

Device: Pulse oximeter